Cleerly LABS (v2.0)
Cleerly, Inc.Cleerly LABS (v2.0) is a web-based software tool designed to help trained medical professionals analyze cardiac computed tomography (CT) images from Coronary CT Angiography (CCTA) scans. It uses machine learning to segment and label coronary arteries, assess plaques, stenosis, and vessel measurements, improving the efficiency and accuracy of coronary artery disease (CAD) assessment. The software enhances medical imaging workflows by automating complex, time-consuming tasks while providing interactive 2D and 3D visualizations.
Intended Use
Cleerly LABS is a web-based software application intended for use by trained medical professionals as an interactive tool for viewing and analyzing cardiac CT data to determine the presence and extent of coronary plaques and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for CAD evaluation.
Technology
Cleerly LABS is a post-processing web-based software that uses deep learning and rule-based calculations on the backend to identify high-quality images, segment and label coronary arteries, and segment lumen and vessel walls. It provides 2D and 3D visualizations for user review and manual editing, and outputs measurements based on user-edited segmentation and markers. Outputs are mathematical calculations, not machine-learning based.
Performance
The device was designed and validated per 21 CFR Part 820.30 and relevant ISO standards, with software testing in pre-production and production environments confirming that the software meets acceptance criteria. Regression testing confirmed that changes did not affect performance. No clinical testing was conducted as non-clinical testing sufficiently supported safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/7/2024
7 months - 2
FDA Approval
3/7/2025
Other devices from Cleerly, Inc.
- Cleerly ISCHEMIA2023 • 510K
- Cleerly Labs v2.02020 • 510K
- Cleerly Labs2019 • 510K
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